Device for performing hemostasis

ABSTRACT

The invention relates to a device for performing hemostasis at two symmetrically located puncture sites in the femoral arteries or veins of a patient. It comprises a beam member ( 6, 8 ) provided with two attachment devices ( 10, 12 ) for pressure pads. There are belts for securing the device to the patient to provide a pressure on the puncture sites, and means ( 18, 20, 24, 26 ) for adjusting the distance between said attachment. The invention also provides a method of controlled hemostasis at two puncture sites in each femoral artery or vein of a patient after catheterization, comprising providing a beam member having two pressure pads, adapted to bear against each puncture site, adjusting the center-to-center distance of said pressure pads by moving at least one of said pressure pads along said beam member, applying said pressure pads at said puncture sites, securing said beam member carrying said pressure pads to the body of said patient, by tightening a belt around the body.

The present invention relates in general to hemostasis, and inparticular to hemostasis of the femoral arteries or veins.

Specifically it relates to a device for performing hemostasis and to toa method of hemostasis.

BACKGROUND OF THE INVENTION AND RELATED ART

Hemostasis of i.a. the femoral artery is performed after e.g.catheterization in order to prevent bleeding. A device for facilitatingsuch hemostasis is disclosed in EP-0 462 088 (Radi Medical). The objectof the device disclosed in said patent is to provide a controlled anddirectional pressure against the puncture in the femoral artery, bvmeans of an inflatable pressure pad attached to an asymmetric arc orbeam member, secured with a strap or belt extending around the body ofthe patient.

In certain circumstances it may be desirable to enter both the right andleft side femoral arteries and veins of both sides of the body.

It has been tried to use two devices of the type disclosed in the abovementioned patent for hemostasis of two punctures. However, it has turnedout that such an approach is difficult to master, because the stabilityof the two devices will be severely impaired, and it will also beinconvenient for the patient.

Another solution has been to use one device of the mentioned type forone puncture, combined with manual compression of the other puncture.

The latter approach is labor intensive and inconvenient for both patientand medical staff.

SUMMARY OF THE INVENTION

The invention seeks to provide a device that overcomes the abovementioned problems with the prior art device.

The problem is solved by providing a femoral compression device forperforming hemostasis at two symmetrically located puncture sites in thefemoral arteries, comprising a beam member provided with two attachmentmeans for disposable pressure pads, and means for adjusting the distancebetween said attachment means to correspond to the distance between saidpuncture sites such that said pressure pads accurately bear against saidpuncture sites at essentially right angles with respect to the bodysurface. The invention is defined in claim 1.

According to the invention there is also provided a method of controlledhemostasis at two puncture sites, as defined in claim 15.

In one embodiment the device comprises two beam halves connected to anadjustment means for providing a variable center-to-center distance.

In another embodiment there is provided a separate attachment device forvariable attachment on one leg of a beam having one integral attachmentmeans.

Further scope of applicability of the present invention will becomeapparent from the detailed description given hereinafter. However, itshould be understood that the detailed description and specificexamples, while indicating preferred embodiments of the invention, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the invention will becomeapparent to those skilled in the art from this detailed description.

The present invention will become more fully understood from thedetailed description given hereinbelow and the accompanying drawingswhich are given by way of illustration only, and thus not limitative ofthe present invention, and wherein

FIG. 1a is a side view of a first embodiment of the invention;

FIG. 1b is a top view with portions broken away of the device in FIG.1a;

FIG. 2a is a side view of a second embodiment of the invention;

FIG. 2b is a top view of the device of FIG. 2a;

FIG. 3a is a side view of a third embodiment of the invention,comprising a femoral compression beam with an adapter;

FIG. 3b is a top view of the device of FIG. 3a;

FIG. 3c is a side view of an adapter;

FIG. 3d is a top view of the adapter of FIG. 3c;

FIG. 4a is a perspective view of another embodiment of an adapter;

FIG. 4b is a side view of the device of FIG. 4a;

FIG. 5a illustrates one way of positioning the device of FIG. 4 on afemoral compression beam;

FIG. 5b illustrates another way of positioning the device of FIG. 4 on afemoral compression beam;

FIG. 5c illustrates another way of positioning the device of FIG. 4 on afemoral compression beam;

FIG. 6a shows a first alternative design of the strap attaching means;and

FIG. 6b shows a second alternative design of the strap attaching means.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1a is a side view of a first embodiment of the compression device,generally identified with reference numeral 2, according to theinvention, and FIG. 1b is a top view of the device in FIG. 1a with aportion broken away.

The shown compression device 2 comprises an overall beam or archstructure 4, having a generally “U”-shaped cross section (the “U”opening upwards as seen in FIG. 1a), and comprising two beam halves 6,8. The beam and the entire assembly has a generally linearconfiguration, i.e. it extends generally in one plane. Each beam half isprovided with an integrally formed attachment means 10 and 12respectively, for attaching inflatable, preferably disposable, pressurepads (not shown) to the beam structure 4.

These pressure pads will in operative position bear against punctures inthe femoral arteries on both sides of the body.

These punctures will be located such that they lie essentially in thesame plane, i.e. on the “upper” side of the body, when the patient lieson his back. Thus, the pressure pads are also located essentially in thesame plane, and the forces from said pads acting on the punctures willbe essentially parallel to each other and directed from above. Thedownward forces will be at essentially right angles with respect to theplane in which the punctures are located.

In one end said beam halves are provided with means 22 for attaching abelt or strap (not shown) for tightening the device around a patient'sbody.

The attachment means 10, 12 comprises snap fit means in the form ofrecesses 14, 16 respectively mating with corresponding pins on thepressure pads. Of course other means of attaching said pressure pads areconceivable, e.g. VELCRO® type means, double adhesive tape, threadsetc., and the method of attachment does not form part of the invention.

The two beam halves 6, 8 are displaceable relative to each other inorder to enable a center-to-center distance between the attachmentmeans, and thereby to adjust the device to fit a particular distancebetween puncture sites to which simultaneous compression is to beapplied. It should be noted that the beam halves are thus movable inrelation to each other in the same linear direction, and thereby thedistance between the lines of force acting on the respective puncturewill also change. The displacement is achieved by providing anadjustment member 18, comprising an elongated element having alongitudinally extending recess 20 formed therein. The adjustment member18 fits in the interior of the beam profile. At the end of each beamhalf opposite the strap attaching means 22 there is provided a “T”-screw24 extending through the beam and through the recess 20 of saidadjustment member 18. Thus, the screw acts as a guide member forenabling a sliding movement of each beam half in said recess 20 alongthe 25 adjustment member 18. A tightening nut 26 is provided such as toenable fixing each beam half at a desire position along the adjustmentmember 18. In the position where the center-to-center distance is theshortest, the free ends of the beam halves 6, 8 contact each other.

In FIG. 2a a second embodiment of the invention is shown.

In this embodiment there is also provided an adjustment member 28.However, in this case the adjustment member is designed as a housing 30,adapted to receive the free ends of each respective beam half 32, 34.The free ends, i.e. the ends opposite the ends provided with the strapattachments 22, are extended in comparison with the free ends of theembodiment of FIGS. 1a-b.

Furthermore, said free ends are designed so as to be slideable insideeach other. This is achieved by removing material from the bottomportion of the “U”-shaped profile of each beam half, to one sidethereof, such that a recess is formed matching the bottom portion of theother beam half not having material removed. This is clear from FIG. 2bwherein the wall portion 36 and the bottom portion 38 belongs to theright hand beam half 34 of FIG. 2a, and the wall portion 40 and thebottom portion 42 belongs to the left hand beam half 32 in FIG. 2a.

Inside the adjustment member 28 there is provided a piston member havinga width and height such that it fills the space remaining inside thehousing when said free ends of the respective beam halves are insertedin the adjustment member 28. In the top portion 46 of the housing 30there is provided a screw 48 which when tightened acts on the piston 44to clamp the free ends of the beam halves located inside said housing 30of the adjustment member 28. In this way the beam halves areindependently adjustable in terms of their positions, and thereby thecenter-to-center distance of the attachment means 10, 12 is alsoadjustable.

The free ends of the beam halves may have other configurations as longas they are movable inside said adjustment member 28.

Thus, it is conceivable to provide the respective free ends withmutually engaging means, such as teeth, that will effectively lock thebeam halves to each other. The tightening means could also have otherdesigns, such as a lever type device of some resilient material.

Turning now to FIGS. 3a-d a third embodiment of the invention isillustrated.

In this embodiment the adjustability of the center-to-center distance ofthe attachment means, is achieved by providing a beam structure 50having a first attachment means 52 integral with the beam structure, anda second attachment means 54 provided on a separate item, below referredto as an adapter 60, connectable at a desired position on said beamstructure 50. In this case the beam structure is asymmetric with respectto beam portions extending from the first attachment 52, i.e. a firstbeam portion 56 is shorter than a second beam portion 58. Each beamportion is provided with a belt attaching means 22 of the same type asin the other embodiments.

The adapter 60 comprises a connector structure 62 having an essentiallyT-shaped base portion 68, on the bottom side of which a pressure padattachment means 54 is mounted. The connector structure 62 is providedwith means for securing it to the longer beam portion 58 of the beamstructure 50 in the form of latch or hook means 64 provided on twoparallel legs 66 extending vertically from the upper side of the baseportion 68 of the connector structure 62. In the shown embodiment thebeam structure 50 has a generally “U”-shaped cross section, thus havingvertical side walls 70 forming engagement sites mating with said latchor hook means 64.

The connector structure further comprises two horizontal, flat legs 72,having their wide dimension in the vertical direction. These legs areadapted to engage with the outermost edge portions 23 of the beltattachment means 22 provided on said longer extension 58 of the beamstructure 50. This guiding function is provided by the presence ofrecesses 74 provided on the inner sides of the legs 72.

Thus, when the adapter 60 is to be positioned on the beam structure 50at a desired site corresponding to the desired center-to-center distanceof the pressure pad attachments 52, 54, the legs 74 are brought oversaid edge portion 23, which fits in said recesses 74, and then the legs66 are pushed over the side walls 70 of the beam portion 58 such thatthe latches 64 snaps around the edge of the side walls 70. In order tofurther secure the adapter at the desired location, there may beprovided a further locking means (not shown), in the form of a loophinged on one leg, and adapted to be brought across the other leg. Byselecting the material of the entire structure to be at least somewhatresilient, the “springy” property of the material will contribute toretain the adapter in a fixed position.

In FIGS. 4 and 5 there is shown a fourth embodiment of the invention,which is a variant of the third embodiment.

Turning now to FIGS. 4a and b, which is a perspective view and a sideview respectively of another embodiment of the adapter. It comprises oneattachment means 80 for a, preferably disposable, pressure pad. Fromsaid attachment means, at the periphery thereof, two vertical legs 82,84 extend in a vertical direction. The legs have a design similar tothat of the legs described in connection with the third embodiment.Thus, the legs are provided with latches or hooks 86, 88 adapted toengage with the side walls of the beam structure of a femoralcompression device.

At the periphery of the attachment means, opposite to where the legs areprovided, there is a support member 90 mounted. It extends in the samevertical direction as the legs 82, 84, and is adapted to rest againstthe upper surface of the beam structure, thereby providing stability tothe adapter means. In order to provide this supporting function in allpositions, the support member 90 is beveled 92 at one edge, in order toaccommodate the sloping surface 94 of the beam in one position of theadapter (se further below).

As can be seen from the Figures, this embodiment may be positioned onthe beam in two orientations, one (FIG. 5a) providing a rather shortcenter-to-center distance, and a second orientation (FIG. 5b-c)providing a range of center-to-center distances.

In order to provide adequate support for the adapter against the beam,there is provided a widening portion 98 on the legs and extendingbetween the legs, and having a lower curved surface 100 with the sameradius of curvature as the curved portions 102, 104 of the beamstructure. When the legs have been snap fitted on the beam, this widenedportion 98 rests against the beam at said curved beam portion. Thus, inthe extreme positions of the adapter (FIG. 5a and c respectively), thiswidened extension of the legs thereby provides the desired support. Alsothe previously mentioned support member 90 in practically all positionsrests against the beam, at least when the belt has been tightened, andthereby two points of support are obtained for the adapter, whichinsures adequate stability in use.

This embodiment is suitable for use together with a commerciallyavailable femoral compression device, obtainable from Radi MedicalSystems, under the trade name FEMOSTOP.

The above disclosed embodiments have been shown with a beam memberhaving strap attaching means 22 provided on extensions of said beammember. Although this is a preferred way of securing the belt from astability and patient comfort point of view, it is conceivable toarrange the strap in other ways. One alternative way is shown in FIGS.6a and 6 b.

In FIG. 6a there is disclosed a device comprising a beam member 110having two recesses 112, 114 in which pressure pad attachment means 116,118 respectively are slidably mounted. A bolt and nut is use forsecuring said attachments in a desired position in said recesses, on thetop surface of the beam 110 there is provided a suitable strap attachingmeans 119 for fixing a strap 120 around the body of a patient. The strapattaching means may be of any suitable design, and does not form part ofthe invention per se.

In FIG. 6b an alternative design is disclosed. Here the pressure padattachment means 122, 124 respectively are integral with one beam half126, 128 respectively. Said beam halves 126, 128 are slideable insideeach other, e.g. in the same way as disclosed in connection with FIG. 2.A strap attaching means 130 is formed as a housings similar to theembodiment of FIG. 2, in which the beam halves are insertable. Thismember is thus integral with the strap attaching means 130.

The method of performing a controlled hemostasis according to theinvention will now be described.

After catheterization of a patient through the femoral arteries orveins, bleeding has to be suppressed. This is achieved by providing adevice according to the invention as disclosed above. Two pressure pads,preferably of a disposable type, are attached to the beam on theattachment means provided on the beam structure.

The center-to-center distance between said pressure pads is adjusted tocorrespond to the distance between puncture sites on the arteries/veins.

The device is placed over the patient such that the pads rest againstthe puncture sites. If needed, further adjustment of saidcenter-to-center distance is made. A belt or strap secured in the strapattaching means provided on the beam is tightened around the patient'sbody. The pressure is maintained for a time sufficient to effectivelystop bleeding, whereupon the pressure is released by loosening thestrap, and removing the device.

The invention being thus described, it will be obvious that the same maybe varied in many ways. Such variations are not to be regarded as adeparture from the spirit and scope of the invention, and all suchmodifications as would be obvious to one skilled in the art are intendedto be included within the scope of the following claims.

What is claimed is:
 1. A device for performing hemostasis at twosymmetrically located puncture sites in the femoral artery or veins of apatient, comprising a beam member (6, 8; 32, 34; 50; 110; 126, 128); twoattachement means (10, 12; 52, 54; 116, 118; 122, 124) for attachingpressure pads, provided on said beam member; means for securing thedevice to a patient to provide a pressure on the puncture sites;characterized in that the attachment means are located essentially inthe same plane; and in that there are provided means for adjusting thedistance between said attachment means along said beam member (6, 8; 32,34; 50; 110; 126, 128) to correspond to the distance between thepuncture sites such that the pressure pads accurately bear against thepuncture sites, at essentially right angles with respect to the plane inwhich the punctures are located, and such that the forces acting on eachrespective puncture site are essentially parallel to each other.
 2. Thedevice of claim 1, wherein said beam member (6, 8; 32, 34) is providedwith attachment means (10, 12) integral with said beam member forsecuring two pressure pads thereon.
 3. The device of claim 2, whereinsaid beam member comprises two halves (6, 8), each carrying oneattachment means (10, 12), and connected to each other by a distanceadjustment member (18; 28) providing for said variable distance.
 4. Thedevice of claim 3, wherein said distance adjustment member is anelongated element (18) comprising a recessed portion (20), and whereineach beam half comprises a protruding element (24) mating with saidrecess such that each beam half is slideable in and along said recess,and wherein each beam half is provided with tightening means (24, 26)for fixing thereof at a selected position in said recess.
 5. The deviceof claim 4, wherein said tightening members comprise a screw and nut(24, 26), said screw also forming said protruding element.
 6. The deviceof claim 3, wherein said distance adjustment member (28) comprises abeam receiving compartment, in which a free end of each said beam halfis insertable, said free ends being adapted to fit inside each other ina sliding relationship, said distance adjustment member (28) beingprovided with tightening means (48, 44) for securing said beam halves ina selected position in said beam receiving space.
 7. The device of claim1, wherein one of said attachment means (52) is integral with said beammember (50), and one attachment means (54) is provided on a separateitem (60) connectable at a selectable position on said beam member (50).8. The device of claim 7, wherein said beam member (50) is asymmetric inthat one portion thereof extending from said integral attachment meansis longer than the other portion, said beam comprising elongatedfastening means (70) extending along said beam, and wherein saidseparate item comprises locking means (64, 66) mating with saidfastening means to insure a secure attachment of said separate item. 9.The device of claim 8, wherein said beam has an arc shape and whereinsaid separate item comprises positioning means mating with selectedportions of said arc shaped beam, such that the separate attachmentmeans is secured in a fixed position on said beam when said lockingmeans engage said fastening means.
 10. Adapter means, usable as aseparate attachment device for a pressure pad on an asymmetric femoralcompression device as claimed in claim 7, with one integral attachmentmeans for a pressure pad, said adapter comprising an attachment means(54; 80) for a pressure pad, and means (64, 66, 68, 72; 84, 88, 98) forattaching the adapter at a selected position on said femoral compressiondevice, such as to provided a second attachment means for a pressure padon said femoral compression device, to render it usable for treating twopunctures at one time.
 11. The adapter as claimed in claim 10,comprising a connector structure (62) having an essentially T-shapedbase portion (68), on the bottom side of which said pressure padattachment means (54) is mounted, said connector structure (62) beingprovided with means in the form of latch or hook means (64) provided ontwo parallel legs (66) extending vertically from the upper side of thebase portion (68) of the connector structure (62) for securing it to thebeam structure (50).
 12. The adapter as claimed in claim 11, wherein theconnector structure further comprises two horizontal, flat legs (72),having their wide dimension in the vertical direction, and adapted toengage with the outermost edge portions (23) of belt attachment means(22) provided on said beam structure (50), said legs being provided withrecesses (74) on the inner sides thereof providing a guiding functionfor the beam member.
 13. The adapter as claimed in claim 10, comprisingtwo vertical legs (82, 84) extending in a vertical direction from saidattachment means (80), at the periphery thereof, the legs being providedwith latches or hooks (86, 88) adapted to engage with the side walls ofthe beam structure of said femoral compression device.
 14. The adapteras claimed in claim 13, comprising a support member (90) mounted at theperiphery of the attachment means, opposite to where the legs areprovided, and extending in the same vertical direction as the legs (82,84), and being adapted to rest against the upper surface of the beamstructure, thereby providing stability to the adapter means.
 15. Amethod of controlled hemostasis at two puncture sites in each femoralartery or vein of a patient after catheterization, comprising: a)providing an essentially linear beam member having two pressure pads,adapted to bear against each puncture site; b) adjusting thecenter-to-center distance of said pressure pads by moving at least oneof said pressure pads along said beam member; c) applying said pressurepads at said puncture sites; d) securing said beam member carrying saidpressure pads to the body of said patient, by tightening a belt aroundthe body.
 16. The method of claim 11, wherein said beam member comprisesattachment means for said pressure pads.